MMR vaccine,vial of single dose

General Description:
MMR vaccine, vial of single dose

The vaccine is a freeze-dried powder containing three viruses - measles, mumps and rubella.

Technical Specifications:
MMR vaccine - Measles, Mumps and Rubella (MMR) combined vaccine, is an attenuated live viral vaccine, freeze dried. Each dose contains not less than 1000 CCID50 (cell culture infective doses 50%) of each, measles, mumps and rubella viruses. Depending on the manufacturer, the vaccine can be formulated to contain not less than 5000 CCID50 of mumps virus. The virus strains contained in the vaccine can differ depending on the manufacturer. The strains which are currently pre-qualified by the WHO are: Edmonston Zagreb, Schwarz and Biken Cam 70 for measles, L-Zagreb, Jeryl Lynn, Urabe for mumps, and RA-27/3 for rubella.MMR vaccine usually contains traces of the antibiotic used during the production process. Rubella component is produced in human diploid cells, measles component can be produced either in human diploid cells or in chicken embryo fibroblasts, and mumps component is produced in chicken embryo fibroblasts. The product has the appearance of yellowish-white dry cake.

Assuming that all three working seeds are available for production, the minimum lead time required for production of monovalent bulks of each of the three components are for measles between 46 and 106 days, for mumps between 48 and 55 days and for rubella between 107 and 130 days.

For information on product specifications, refer to the WHO website on Prequalified Vaccines.

https://www.who.int/immunization_standards /vaccine_quality/PQ_vaccine_list_en/en/

Administration:
Immunization consists of a single dose of 0.5 ml injected percutaneously (subcutaneous or intra-muscular), preferably in the upper arm. A sterile needle and sterile syringe must be used for each injection. Because of sensitivity to ultraviolet light, avoid exposing the vaccine to sunlight. Once the vaccine has been reconstituted, it should be used the same day (preferably immediately, but by no means beyond six (6) hours of reconstitution), and only then if the vial has been maintained between +2°C and +8°C and protected from sunlight. Any opened container remaining at the end of a session (within six hours of reconstitution) should be discarded. The vaccine vial monitor, if present, is removed on reconstitution.

The diluent supplied is specially designed for use with this vaccine. Only this diluent may be used to reconstitute the vaccine. Do not use diluents from other types of vaccine or for MMR vaccine from other manufacturers. Water for injection may NOT be used for this purpose. Using an incorrect diluent may result in damage to the vaccine and/or serious reactions to those receiving the vaccine. Diluent must not be frozen but must be cooled between +2°C and +8°C before reconstitution.

Immunization Schedule:
In countries where the incidence and mortality from measles is high in the first year of life, the recommended age for immunization using MMR is at 9 months of age (270 days) or soon after. In countries where measles infection occurs later in life (due to sustained high vaccine coverage), the age of immunization can be moved to 12-15 months. A second opportunity is needed both to increase the chance that every child receives at least one dose of measles-containing vaccine and to increase the proportion of the population that is fully immunized. The second dose of measles-containing vaccine can be given through routine or supplemental activities. MMR vaccine can be given safely and effectively simultaneously with DTP, Td, TT, BCG, polio (OPV and IPV), haemophilus influenzae type b, hepatitis B, and yellow fever vaccines and vitamin A supplementation.

The combination vaccine produces an immunological response to each antigen equivalent to that following administration of each of the single antigen products. The safety and immunogenicity of this combination vaccine appears to be similar to that of its individual constituents.

Transport and Storage:
Freeze-dried measles, mumps and rubella combined vaccine should be kept frozen at -20°C or in the refrigerator between +2°C and +8°C until used. The vials of vaccine and the diluents should be transported together. The vaccine should be protected from sunlight.